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| Sponsor: | Novacea |
|---|---|
| Collaborator: |
None |
| Information provided by: | Novacea |
| ClinicalTrials.gov Identifier: | NCT00285675 |
Purpose
The purpose of this study is to monitor the safety of continued DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 (ASCENT) or DN101-004 (NSCLC) Studies.
| Condition | Intervention | Phase |
|---|---|---|
|
Androgen Independent Prostate Cancer (AIPC) Non Small Cell Lung Cancer (NSCLC) |
Drug: DN-101 (calcitriol) - Drug |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Continuation Study of DN-101 (Calcitriol) and Docetaxel in Subjects Previously Enrolled in Studies DN101-002 or DN101-004 |
| Estimated Enrollment: | 25 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | January 2008 |
This is a multicenter, open-label trial of DN-101 and docetaxel combination therapy to monitor the safety of ongoing DN-101 and docetaxel treatment for subjects previously enrolled in DN101-002 or DN101-004 studies. For subjects enrolled in DN101-002 study, only subjects randomized to the DN-101 treatment arm and are currently receiving study drug (including subjects on study suspension / holiday) will be included in the current study. For subjects enrolled in DN101-004 study, only subjects who are receiving study treatment will be included.
Safety will be assessed throughout the study. Safety evaluations will consist of a modified physical exam (vital signs and weight) and laboratory assessments. Modified physical exam should be performed at the beginning of each treatment cycle. Docetaxel-related laboratory assessments will be performed per standard of care as noted in the labeling. DN-101-related laboratory assessments for serum calcium and serum creatinine will be performed at the beginning of each treatment cycle. Clinically significant abnormal laboratory values will be reported as adverse events.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Alta Bates Comprehensive Cancer Center | |
| Berkeley, California, United States, 94704 | |
| Kaiser Permanente Medical Group, Northern California | |
| Vallejo, California, United States, 94589 | |
| Pacific Hematology Oncology Associates | |
| San Francisco, California, United States, 94115 | |
| United States, New York | |
| Columbia Presbyterian Medical Center | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Piedmont Hematology Oncology Associates | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Oregon | |
| NW Kaiser Permanente Portland | |
| Portland, Oregon, United States, 97227 | |
| Oregon Health & Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| Alta Bates Comprehensive Center | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Pennsylvania | |
| University of Pittsburgh,William Copper Ambulatory Care, Pavillion Hellman Cancer Center | |
| Pittsburgh, Pennsylvania, United States, 15232-1305 | |
| United States, Texas | |
| Tyler Cancer Center | |
| Tyler, Texas, United States, 75702 | |
| United States, Washington | |
| Northwest Cancer Specialists Vancouver Office | |
| Vancouver, Washington, United States, 98684 | |
| Canada, Alberta | |
| Tom Baker Cancer Centre | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Cross Cancer Institute, Department of Medicine | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
More Information
| Study ID Numbers: | 011-016 |
| Study First Received: | January 31, 2006 |
| Last Updated: | May 30, 2006 |
| ClinicalTrials.gov Identifier: | NCT00285675 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
Calcitriol, DN-101, Androgen Independent Prostate Cancer (AIPC), Prostate Cancer, Non Small Cell Lung Cancer (NSCLC) |
|
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Physiological Effects of Drugs Calcium Channel Agonists Urogenital Neoplasms Bone Density Conservation Agents Calcitriol Membrane Transport Modulators Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Vitamins |
Vasoconstrictor Agents Micronutrients Respiratory Tract Neoplasms Neoplasms by Histologic Type Growth Substances Cardiovascular Agents Genital Diseases, Male Pharmacologic Actions Carcinoma Neoplasms Lung Diseases Prostatic Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |